UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051044 |
|---|---|
| Receipt number | R000058079 |
| Scientific Title | Translational research study of NIVOlumab RE-adminiTration for UnResectable/recurreNt gaStric cancer |
| Date of disclosure of the study information | 2023/05/12 |
| Last modified on | 2023/05/12 14:15:05 |
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Basic information
Public title
Translational research study of NIVOlumab RE-adminiTration for UnResectable/recurreNt gaStric cancer
Acronym
NIVO-RETURNS TR
Scientific Title
Translational research study of NIVOlumab RE-adminiTration for UnResectable/recurreNt gaStric cancer
Scientific Title:Acronym
NIVO-RETURNS TR
Region
| Japan |
Condition
Condition
Unresectable/recurrent gastric cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore biomarkers for novel predictors of response to nivolumab in the re-administration of nivolumab for unresectable advanced or recurrent gastric cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FCM analysis
FCM will use Immunity Research Inc.'s measurement kit to evaluate the following factors, and search for factors related to OS, PFS, and RR.
CD4: CD25, CD62L, CXCR3, CCR4, CCR6, Th1, Th7R (Th1/Th17, CCR6 SP), Th17
CD8: CCR7, CD45RA, EM, EMRA, CM naive
Key secondary outcomes
No
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
According to the study "Prospective observational study of efficacy and safety in re-administration of nivolumab for unresectable advanced/recurrent gastric cancer"
Key exclusion criteria
According to the study "Prospective observational study of efficacy and safety in re-administration of nivolumab for unresectable advanced/recurrent gastric cancer"
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Muro |
Organization
Aichi Cancer Center
Division name
Department of Clinical Oncology
Zip code
464-8681
Address
1-1Kanokoden,Chikusa-ku,Nagoyashi,Aichi Japan
TEL
052-762-6111
kmuro@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Kodama |
Organization
Aichi Cancer Center
Division name
Department of Clinical Oncology
Zip code
464-8681
Address
1-1Kanokoden,Chikusa-ku,Nagoyashi,Aichi Japan
TEL
052-762-6111
Homepage URL
https://cancer-c.pref.aichi.jp/
h.kodama@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Ono Pharmaceutical Co., Ltd.
Bristol-Myers Squibb Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi cancer center,Institutional Review Board
Address
1-1Kanokoden,Chikusa-ku,Nagoyashi,Aichi Japan
Tel
052-762-6111
irb-jimu@aichi-cc.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
愛知県がんセンター（愛知県）、市立札幌病院（北海道）、独立行政法人国立病院機構 名古屋医療センター（愛知県）、近畿大学病院（大阪府）、独立行政法人国立病院機構 四国がんセンター（愛媛県）、東北大学医学部附属病院（宮城県）、宮崎大学医学部附属病院（宮崎県）、富山大学附属病院（富山県）、NTT東日本関東病院（東京都）、手稲渓仁会病院（北海道）、県立広島病院（広島県）、社会医療法人財団慈泉会 相澤病院（長野県）、聖マリアンナ医科大学病院（神奈川県）、川崎医科大学附属病院（岡山県）、北海道大学病院（北海道）、大崎市民病院（宮城県）、神戸市立医療センター中央市民病院（兵庫県）、JCHO九州病院（福岡県）、九州大学病院（福岡県）、大阪医科薬科大学病院（大阪府）、名古屋市立大学病院（愛知県）、熊本大学病院（熊本県）、神奈川県立病院機構 神奈川県立がんセンター（神奈川県）、藤田医科大学病院（愛知県）、兵庫医科大学病院（兵庫県）、東京女子医科大学病院（東京都）、日本赤十字社長崎原爆病院（長崎県）、国家公務員共済組合連合会 斗南病院（北海道）、大阪赤十字病院（大阪府）、岐阜大学医学部附属病院（岐阜県）、独立行政法人国立病院機構 京都医療センター（京都府）、静岡県立総合病院（静岡県）、がん研究会有明病院（東京都）、釧路労災病院（北海道）、九州がんセンター（福岡県）、高知大学医学部附属病院（高知県）、関西医科大学附属病院（大阪府）、慶應義塾大学病院（東京都）、総合病院 土浦協同病院（茨城県）、山形大学医学部附属病院（山形県）、新潟県立がんセンター新潟病院（新潟県）、名古屋大学医学部附属病院（愛知県）、京都府立医科大学病院（京都府）、山梨大学医学部附属病院（山梨県）、千葉県がんセンター（千葉県）、広島市立北部医療センター安佐市民病院（広島県）、広島市立広島市民病院（広島県）、日本海総合病院（山形県）、トヨタ記念病院（愛知県）、茨城県立中央病院・茨城県地域がんセンター（茨城県）、東邦大学医療センター大森病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 04 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
CD4 T cells and their lineage cells have been shown to be associated with efficacy of immune checkpoint inhibitors (ICIs) in lung cancer. We will also examine whether it can be a predictor of efficacy when re-challenging ICI for gastric cancer.
Management information
Registered date
| 2023 | Year | 05 | Month | 12 | Day |
Last modified on
| 2023 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058079
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| Registered date | File name |
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